Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

July 3, 2026 updated by: Bayer

An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation

The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria

  • Signed and dated written informed consent
  • Age ≥18 years
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • Documented disease progression after treatment with at least one prior systemic therapy for advanced disease
  • Documented HER2 activating mutation
  • Expected minimum life expectancy of 12 weeks
  • Performance status of 0 or 1
  • Participants must be able to take oral medication
  • Blood test results within certain ranges
  • Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment
  • Adequate cardiac function
  • Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose
  • Ability to receive prescription of loperamide from the treating physician

Exclusion Criteria

  • Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy
  • Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2
  • Symptomatic or unstable brain metastases
  • Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP
  • Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease
  • Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation
  • Any uncontrolled intercurrent illness or condition including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, ongoing or active infection (including active clinical tuberculosis), renal transplant or psychiatric illness/social situations that would limit compliance
  • Pregnancy or lactation
  • History of clinically significant cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22913
  • 22978 (Other Identifier: Bayer ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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